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Sylvant

(Siltuximab)

Phase 3Monoclonal antibody

RRECORDATI GROUP

Siltuximab is used to treat a rare blood cancer called multicentric Castleman disease, which causes swollen lymph nodes and inflammation throughout the body.[1] Sylvant is currently being investigated across 11 indications[3], with its most advanced program in Phase 3.[1]

Sylvant is one of 184 small molecule programs targeting Immune System Disease. It is currently in Phase 3.

11

Indications

32

Total Trials

9

Active Trials

183

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Immune System DiseaseUnknown

Giant Lymph Node HyperplasiaUnknown

AnemiaUnknown

Idiopathic Multicentric Castleman DiseaseUnknown

Non-Hodgkin LymphomaRecruiting

B-Cell Acute Lymphoblastic LeukemiaRecruiting

Chronic Lymphocytic LeukaemiaNot yet recruiting

SchwannomatosisRecruiting

AntibodyRecruiting

Multiple MyelomaCompleted

Immune System DiseasePreclinical

Unknown

Giant Lymph Node HyperplasiaPreclinical

Unknown

AnemiaPreclinical

Unknown

Idiopathic Multicentric Castleman DiseasePreclinical

Unknown

Non-Hodgkin LymphomaPhase 1

Recruiting

B-Cell Acute Lymphoblastic LeukemiaPreclinical

Recruiting

Chronic Lymphocytic LeukaemiaPhase 2

Not yet recruiting

SchwannomatosisPhase 2

Recruiting

AntibodyPhase 1

Recruiting

Multiple MyelomaPhase 3

Completed

Showing 10 of 11 indications

Competition

Competitive Landscape

282 competitors in Multiple Myeloma

#DrugCompanyPhaseTrials

Empliciti

Bristol-Myers Squibb

TALVEY

Johnson & Johnson

Sarclisa

AAzienda U.S.L. 1 di Massa e Carrara

Biaxin

Xpovio

KKaryopharm Therapeutics Inc

Treanda

AAzurity Pharmaceuticals

Vepesid

Mozobil

GGenzyme, a Sanofi Company

BLENREP

GGlaxo Dba Glaxosmithkline

Sylvant

RRECORDATI GROUP

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Multiple Myeloma

NCT03315026

Q3 2027

Phase 2Recruiting

Multiple Myeloma

NCT07106671

Q4 2027

Phase 2Recruiting

Multiple Myeloma

NCT06679829

Q3 2028

Phase 1Recruiting

Antibody

NCT06990711

Phase 1Recruiting

Non-Hodgkin Lymphoma

NCT06447376

Clinical

Trials by Indication[1]

Multiple Myeloma8 trials

A Study of the Safety and Efficacy of CNTO 328 and Bortezomib to Bortezomib Alone in Patients With Relapsed or Refractory Multiple Myeloma

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT00401843·307 enrolled

A Phase II Study of Siltuximab for CRS/ICANs After CAR-T in Multiple Myeloma

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT07106671·20 enrolled

A Study of Siltuximab (Anti- IL 6 Monoclonal Antibody) in Patients With High-risk Smoldering Multiple Myeloma

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT01484275·85 enrolled

Show 5 more trials

Lenalidomide/Bortezomib/Dexamethasone & CNTO 328 in Transplant Eligible Newly Diagnosed Multiple Myeloma (MM)

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT01531998·14 enrolled

A Study of Melphalan With or Without Siltuximab in People With Multiple Myeloma Having an Autologous Stem Cell Transplant

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT06679829·215 enrolled

An Efficacy and Safety Study of Siltuximab in Participants With Relapsed or Refractory Multiple Myeloma

Completed·CCentocor, Inc.·Phase 2·NCT00402181·53 enrolled

A Phase 1 Study of CNTO 328 (Siltuximab) in Relapsed or Refractory Multiple Myeloma

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01309412·9 enrolled

Siltuximab to Decrease Symptom Burden After Autologous Stem Cell Transplantation for Patients With Multiple Myeloma and AL Amyloidosis

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT03315026·30 enrolled

Cytokine Release Syndrome2 trials

Siltuximab for Cytokine Release Syndrome Prophylaxis Prior to tx w/ Teclistamab in RRMM

Withdrawn·JJack Khouri, MD·Phase 2·NCT06352866

A Phase II Pilot Study to Evaluate the Role of Siltuximab in Treatment of Cytokine Release Syndrome (CRS) and Immune Effector Cell Associated Neurotoxicity (ICANS) Related to Chimeric Antigen Receptor T-Cell Therapy (CAR-T) in Hematological Malignancies

Completed·UUniversity of Alabama at Birmingham·Phase 2·NCT04975555·20 enrolled

Lymphoma1 trial

Siltuximab for the Prevention of CAR T Cell Related Cytokine Release Syndrome in Patients With CD19 Positive Non-Hodgkin Lymphoma

Completed·TTimothy Voorhees·Phase 1·NCT05665725·11 enrolled

Efficacy and Safety1 trial

A Study to Evaluate the Efficacy and Safety of CNTO328 Plus Best Supportive Care in Multicentric Castleman's Disease

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT01024036·79 enrolled

Pancreatic Cancer1 trial

Siltuximab and Spartalizumab in Patients With Metastatic Pancreatic Cancer

Completed·EEmory University·Phase 1/2·NCT04191421·35 enrolled

19 more indications

Pneumonia1 trial

Efficacy and Safety of Siltuximab vs. Corticosteroids in Hospitalized Patients With COVID-19 Pneumonia

Completed·JJudit Pich Martínez·Phase 2·NCT04329650·163 enrolled

Acute Myeloblastic Leukaemia1 trial

Dose-escalation of Siltuximab in Combination With Idarubicin and Cytarabine Chemotherapy in Patients With Acute Myeloblastic Leukaemia (AML) With Poor Prognosis: SILTUXILAM

Unknown status·NNantes University Hospital·Phase 1·NCT05697510·12 enrolled

Immune-related Adverse Events1 trial

Siltuximab for the Prevention of Severe Immune-Related Adverse Events During Immune Checkpoint Inhibitor Rechallenge in Patients With Advanced Cancer, CIRES Trial

Recruiting·YYuanquan Yang·Phase 2·NCT06470971·40 enrolled

COVID-191 trial

Treatment of COVID-19 Patients With Anti-interleukin Drugs

Completed·UUniversity Hospital, Ghent·Phase 3·NCT04330638·342 enrolled

Monoclonal Gammopathy1 trial

A Study Evaluating the Effects of Siltuximab on the Heart in Patients With Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma, or Indolent Multiple Myeloma

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01219010·30 enrolled

Castleman disease1 trial

Siltuximab In Siltuximab-RElapsed/REfractory Multicentric CAstleman Disease

Terminated·RRECORDATI GROUP·Phase 2·NCT04838860·22 enrolled

Schizophrenia1 trial

Siltuximab in Schizophrenia

Unknown status·BBrian Miller·Phase 1/2·NCT02796859·30 enrolled

Type 1 Diabetes1 trial

Modulation of STAT3 Signaling With Siltuximab in Type 1 Diabetes

Completed·—·Phase 1·NCT02641522·10 enrolled

Leukemia1 trial

Siltuximab in Large Granular Lymphocytic Leukemia (LGLL)

Terminated·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT05316116·6 enrolled

ARDS1 trial

SILtuximab in Viral ARds (SILVAR) Study

Terminated·RRECORDATI GROUP·Phase 3·NCT04616586·555 enrolled

Myelodysplastic Syndrome1 trial

A Study Comparing Siltuximab Plus Best Supportive Care to Placebo Plus Best Supportive Care in Anemic Patients With International Prognostic Scoring System Low- or Intermediate-1-Risk Myelodysplastic Syndrome

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT01513317·76 enrolled

Essential Thrombocythemia1 trial

Siltuximab in Treating Patients With Primary, Post-Polycythemia Vera, or Post-Essential Thrombocythemia Myelofibrosis

Withdrawn·NNorthwestern University·Phase 1·NCT02805868

Treatment1 trial

A Study to Evaluate the Safety of Long-term Treatment With Siltuximab in Patients With Multicentric Castleman's Disease

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT01400503·60 enrolled

Prostate Cancer1 trial

A Safety and Efficacy Study of Siltuximab (CNTO 328) in Male Subjects With Metastatic Hormone-Refractory Prostate Cancer (HRPC)

Terminated·CCentocor, Inc.·Phase 2·NCT00385827·106 enrolled

B-cell acute lymphoblastic leukemia1 trial

A Phase 2/3, Randomized, Open-Label, Comparison Study of MK-1045 Versus Blinatumomab in Participants With Relapsed or Refractory CD19+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Recruiting· Merck & Co. logo

Merck & Co.·Preclinical·NCT07570173·340 enrolled

Antibody1 trial

A Phase 1 Clinical Trial of Siltuximab for the Treatment of Antibody-Mediated Rejection After Lung Transplantation (Siltux-AMR)

Recruiting·WWashington University School of Medicine·Phase 1·NCT06990711·30 enrolled

Chronic Lymphocytic Leukaemia1 trial

A Phase 2, Open-label, Multicenter Study to Determine the Safety, Tolerability, and Efficacy of MK-1045 in Participants With Hematologic Malignancies

Not yet recruiting· Merck & Co. logo

Merck & Co.·Phase 2·NCT07709000·60 enrolled

Schwannomatosis1 trial

Screening Trial for Pain Relief in Schwannomatosis (STARFISH)

Recruiting·MMassachusetts General Hospital·Phase 2·NCT05684692·40 enrolled

Non-Hodgkin Lymphoma1 trial

Pilot Safety-feasibility Study of Cytokine Release Syndrome Prophylaxis and Treatment With Siltuximab Prior to Epcoritamab

Recruiting·TTaylor Brooks·Phase 1·NCT06447376·20 enrolled

Regulatory

FDA Approval Timeline[4]

Apr 23, 2014

SYLVANT

BLA BLA125496

Sources

References

[1]
ClinicalTrials.gov — 32 trial records for Siltuximab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Siltuximab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Siltuximab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA125496). U.S. Food & Drug Administration.
[5]
SEC EDGAR — RECORDATI GROUP company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Interleukin-6 Antagonist[2]
Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: RRECORDATI GROUP

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